The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis

November 1997

Issue: 52 Food and Drug Law Journal 409-428 (1997)

Prior to 1993, human tissue banking and transplantation practices were largely unregulated in the United States. To the extent that federal regulatory controls were in place before that time, they represented a piecemeal approach that left most of the industry untouched by the Food and Drug Administration (FDA). In response to growing concern over such issues as the transmission of communicable disease through tissue transplants and the safety of tissue imported into the United States, FDA promulgated an interim rule that covered the industry in a more sweeping manner. In addition, Congress has several times attempted to craft a legislative solution. This article traces the history of FDA’s regulation in the human tissue area, discusses the current regulatory scheme, and analyzes various congressional efforts to impose a regulatory framework.

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